Regulatory Affairs Director for Pharmaceutical Product Development
6 days ago
Job Title: Regulatory Affairs Director for Pharmaceutical Product Development
About Stirling Q&R:
We are a leading pharmaceutical company in the San Francisco Bay Area, committed to developing and commercializing innovative therapeutic products. Our dynamic environment offers excellent opportunities for growth and professional development.
Job Description:
This is a leadership role that will lead efforts in developing and executing global regulatory strategies for our product portfolio. The successful candidate will have expertise in regulatory requirements, excellent communication and interpersonal skills, and experience in cross-functional team management.
Key Responsibilities:
- Develop and execute global regulatory strategies for assigned products throughout their lifecycle.
- Provide regulatory guidance to cross-functional teams on various issues.
- Anticipate and resolve potential regulatory challenges aligned with business objectives.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, NDAs, BLAs, and international equivalents.
- Respond to health authority queries and manage information requests.
- Guide interactions with regulatory agencies, such as FDA and EMA.
- Prepare for and participate in key regulatory meetings.
- Maintain positive relationships with regulatory authorities.
- Team Management: Mentor junior Regulatory Affairs professionals, providing guidance for their development.
- Foster continuous improvement and Regulatory excellence within the team.
- Interface effectively with internal stakeholders and external partners.
Requirements:
The ideal candidate should possess an advanced degree in life sciences (Ph.D., Pharm.D., or M.D.) and minimum 8-10 years of pharmaceutical industry experience in Regulatory Affairs, with at least 3 years in a supervisory role.
Qualifications:
- Strong understanding of regulatory requirements of FDA, EMA, and ICH throughout the product development process.
- Proven track record of successful submissions and approvals with excellent project management, communication, and leadership skills.
- Experience in oncology, rare diseases, or other specialty therapeutic areas is highly desirable.
Benefits:
- Competitive compensation package includes attractive base salary ($150,000 - $180,000), annual bonus, comprehensive health and wellness benefits, 401(k) plan company match, generous paid time off, and holidays.
Career Growth Opportunities:
This role presents a great opportunity to make a real difference in patients' lives while advancing your career in a supportive and innovative environment. If you have a passion for regulatory affairs and seek a leadership role at a dynamic pharmaceutical company, we encourage you to apply.
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